Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Organon | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.
For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contraceptive vaginal ring | Active Comparator | Contraceptive vaginal ring (NuvaRing) |
|
| Oral contraceptive pill | Active Comparator | Oral contraceptive pill (Ortho Tri-cyclen Lo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho Tri-cyclen Lo | Drug | Low dose oral contraceptive |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence Rate (Rate of Perfect Method Use) | "Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles | For the first 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Rate | at 3 months | |
| Continuation Rate | Rate of intention to continue the contraceptive method at 3 months | at 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa L Gilliam, MD, MPH | University of Chicago, Section of Family Planning | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago, Section of Family Planning | Chicago | Illinois | 60637 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17586133 | Background | Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. doi: 10.1016/j.contraception.2007.03.009. Epub 2007 May 24. | |
| 20177280 | Derived | Gilliam ML, Neustadt A, Kozloski M, Mistretta S, Tilmon S, Godfrey E. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):503-510. doi: 10.1097/AOG.0b013e3181cf45dc. |
Not provided
Not provided
We screened 276 participants, of whom 273 were eligible because 3 of them did not meet inclusion criteria.
We recruited 276 participants between March 2006 and December 2008 at two Midwest university-based sites through passive (online and subway advertisements) and active recruitment (referrals from local clinics and health care providers).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Contraceptive Vaginal Ring | Contraceptive vaginal ring (NuvaRing) |
| FG001 | Oral Contraceptive Pill | Oral contraceptive pill (Ortho Tri-Cyclen Lo) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Contraceptive Vaginal Ring | Contraceptive vaginal ring (NuvaRing) |
| BG001 | Oral Contraceptive Pill | Oral contraceptive pill (Ortho Tri-Cyclen Lo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence Rate (Rate of Perfect Method Use) | "Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles | Posted | Number | Percentage of Participants | For the first 3 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contraceptive Vaginal Ring | Contraceptive vaginal ring (NuvaRing) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
This study is an randomized controlled trial offering internal but not necessarily external validity. Thus, we do not know whether these findings would be replicable in other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Gilliam | Department of Obstetrics and Gynecology, The University of Chicago | 773-834-0840 | mgilliam@babies.bsd.uchicago.edu |
Not provided
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NuvaRing |
| Device |
Contraceptive vaginal ring |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| University of Illinois | Chicago | Illinois | United States |
| Adverse Event |
|
| Physician Decision |
|
| Did not complete survey |
|
| Early termination(No sexual activity) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Living arrangement | Number | participants |
|
| Location | Number | participants |
|
| Religious preference | Number | participants |
|
| Relationship status | Number | participants |
|
| Age at sexual debut | Only of those who had ever had vaginal sexual intercourse ; 125 for contraceptive vaginal ring and 127 for oral contraceptive. | Median | Full Range | Years |
|
| Vaginal sex in the past month | Only of those who had ever had vaginal sexual intercourse ; 125 for contraceptive vaginal ring and 127 for oral contraceptive. | Number | participants |
|
| Frequency of sex in current or most recent relationship | Only of those who had ever had vaginal sexual intercourse ; 125 for contraceptive vaginal ring and 127 for oral contraceptive. | Number | participants |
|
| Pregnant ever | Only of those who had ever had vaginal sexual intercourse ; 125 for contraceptive vaginal ring and 127 for oral contraceptive. | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Satisfaction Rate | 26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart) | Posted | Number | Percentage of Participants | at 3 months |
|
|
|
|
| Secondary | Continuation Rate | Rate of intention to continue the contraceptive method at 3 months | 26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart) | Posted | Number | Percentage of Participants | at 3 months |
|
|
|
|
| Post-Hoc | Continuation Rate | Rate of intention to continue the contraceptive method at 6 months | At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis. | Posted | Number | Percentage of Participants | at 6 month (3 month after the end of the study period) |
|
|
|
|
| 0 |
| 136 |
| 100 |
| 136 |
| EG001 | Oral Contraceptive Pill | Oral contraceptive pill (Ortho Tri-Cyclen Lo) | 0 | 137 | 105 | 137 |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Headaches | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
| Vaginal discomfort | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Missing |
|
| Missing |
|
| Missing |
|